CAPA Process Analyst - Intellectt INC
Santa Rosa, CA
About the Job
Job Title: CAPA Process Analyst II
Location: Santa Rosa, CA
Duration:10+ Months
Shift: 8 AM - 5 PM
Key Responsibilities:
- Lead CAPA (Corrective and Preventive Action) investigations and ensure timely completion of activities.
- Facilitate cross-functional teams to determine root causes of nonconformities and ensure effective CAPA plans.
- Ensure CAPAs are implemented promptly for new or improved products, processes, and systems.
- Manage CAPA documentation to ensure audit readiness for internal and external audits.
- Produce reports and metrics to identify trends and initiate improvement actions.
- Prioritize workload based on business needs and ensure compliance with regulatory standards.
- Support the organization in achieving goals and ensure effective communication and teamwork.
Required Qualifications:
- Bachelor's degree in Engineering or Life Sciences.
- Experience with the CAPA process in medical devices or laboratories.
- Strong communication and technical writing skills.
Preferred Qualifications:
- Understanding of statistics, FMEA, and ASQ CQE certification.
- Knowledge of Quality requirements in CLIA, CAP regulations, or similar regulated industries.
Source : Intellectt INC